BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 4949089 · Received July 29, 2015

    Report

    Report Number
    9612164-2015-01317
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    July 9, 2015
    Report Date
    September 14, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: STABILITY MEMBER HAD BEEN CUT 3.8CM DISTAL TO STRAIN RELIEF. ONLY 39.8CM OF THE RETRACTABLE SHEATH WAS RETURNED. THERE WAS 10.5CM OF THE INNER MEMBER REMAINING DISTAL TO THE DISTAL END OF THE MIDDLE MEMBER. THERE WERE NUMEROUS KINKS VISIBLE ON THE INNER MEMBER SHAFT. THE DISTAL TIP, THE PROXIMAL AND THE DISTAL INNER MEMBER MARKERS HAD DETACHED. THE MIDDLE MEMBER HAD PULLED OUT AT THE MIDDLE MEMBER/HYPOTUBE BOND. STILL PROCEDURAL IMAGE REVIEW: THREE STILL IMAGES WERE PROVIDED. THE EXPANSION OF THE STENT APPEARS TO HAVE BEEN RESTRICTED AND THERE IS EVIDENCE OF GUIDEWIRE BIAS WITHIN THE STENT. THE DEPLOYED STENT CONFIRMS THAT THE STENT HAS CONFORMED TO THE LESION MORPHOLOGY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE A COMPLETE SE DEVICE TO TREAT A LESION IN THE LEFT MID SFA. THE TARGET LESION EXHIBITED A LITTLE CALCIFICATION. THE DEVICE WAS PREPPED AND INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE STENT DEPLOYED QUICKLY BUT THE DELIVERY SYSTEM GOT CAUGHT AT THE TIP RESULTING IN THE STENT BEING PULLED BACK INTO ITSELF. THE PHYSICIAN HAD TO CUT THE SHAFT INTO PIECES TO REMOVE THE DELIVERY SYSTEM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494429 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND 0007575734

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention